All posts tagged drug

If you want to test a new drug, you’ll often need to do blind clinical trials, where nobody–neither the subjects of the tests, nor the people running them–know who is getting the experimental drug and who isn’t.

It’s a system that has worked well for drug makers for decades, removing potential sources of bias from test results. But the blind trial is running into some very 21st century challenges lately, reports the WSJ’s Amy Dockser Marcus:

On Facebook groups, online forums and blogs, some patients are effectively jeopardizing the blind. In trials for hepatitis C, multiple sclerosis and ALS (Amyotrophic lateral sclerosis, also known as Lou Gehrig’s disease), patients have been sharing details of their reactions and trying to figure out whether they are getting the active drug.

Patients also swap tips on how to get accepted into trials, even if they don’t meet all the requirements. Some who are in trials collect and analyze their medical data and others’ to get an early indication of whether a drug will be a success.

Since 2000, Pfizer has relied on three huge mergers to bolster its top line, plug holes in its product portfolio and appease investors. But those deals—in which Pfizer acquired Warner-Lambert, Pharmacia and then Wyeth—mostly bought time as the drug maker cut costs, narrowed its R&D focus and then began raising its dividend.

Since being promoted to CEO three years ago, though, Mr. Read repeatedly has promoted the idea of splitting the drug maker into three separate units and pooh-poohed the notion that huge deals would be pursued in order to chase revenue. Specific financial details for those entities are, in fact, due to be released next month. Read More »

Tweet this: As drug makers experiment with the use of social media to engage consumers, they are decidedly reluctant to use these tools to bolster their efforts in designing and developing clinical trials, according to a new survey.

For example, while only one in 10 clinical trials run by drug makers have recruited participants through social media channels, the majority have yet to try it. Why? Concerns range from protecting patient privacy to equally sticky issues such as patients who publicly distort adverse event experiences or introduce research bias by sharing treatment information online with others.

“Like it or not, social media communities as a forum for interaction and engagement are here to stay,” says Ken Getz, the director of sponsored research programs at the Tufts University Center for the Study of Drug Development, which queried 17 drug makers and three contract research organizations.

On its way to becoming the world’s biggest seller of generic medicines, Teva Pharmaceutical Industries Ltd. was known for its fierce efforts to end patent protection for brand-name drugs. But now the Israeli drug maker is pulling out all the stops to protect one of its own brand-name drugs from such a reckoning.

Today, the U.S. Supreme Court said it would hear Teva’s appeal of an appeals court decision that could have paved the way for generic versions of multiple-sclerosis drug Copaxone.

Even though it’s a brand-name medicine at a largely generic drug maker, Copaxone is one of Teva’s most important products. Last year, Copaxone rung up $4.3 billion of the company’s $20.3 billion in total revenues. And analysts figure it accounts for 40% or more of Teva’s profit.

The Food and Drug Administration has been in discussions with the e-cigarette industry about a possible online-sales ban of the product, as it prepares a package of proposed regulations for the increasingly popular devices, people familiar with the matter said.

The FDA, which warned in 2009 that e-cigarettes could pose health risks, has been meeting with e-cigarette makers in recent weeks to hear their views on regulations for the industry. The agency is expected to formally unveil its proposals in October, after several delays.

The “listening sessions” at FDA headquarters in Silver Spring, Md., north of Washington, are part of a series of meetings, including conference calls, that have been organized at the industry’s request. At least 20 FDA staffers have attended the gatherings at the FDA headquarters, the people familiar with the matter said, as the agency prepares its proposals for public comment.

British drug giant GlaxoSmithKline, trying to spur the discovery of new medicines, is making a contest out of it, inviting scientists in the United States and Canada to submit their drug research ideas.

The company is scheduled to formally announce the competition tomorrow. It hasn’t set a firm target but expects to pick about ten projects, and will provide as much as $10 million in total assistance, including the reagents needed to pursue the research and the screening to see if there are any molecules that seem to have activity against a disease target.

The goal is to tap into promising research quickly, without going through the initial contract negotiations that can delay projects from getting off the ground for long stretches, GlaxoSmithKline says. Many drug makers have been trying to access promising research at outside laboratories, but some university researchers complain about lengthy, difficult negotiations over intellectual property rights and academic freedom.

In the GlaxoSmithKline experiment, these contract talks would come later, if the early collaboration between company and researcher turns up a promising drug target and the sides want to partner further on using those findings to develop a potential medicine.

“We are excited to receive submissions in all therapeutic areas and look forward to being part of the researcher’s journey in making a difference,” said Pearl Huang, who runs GlaxoSmithKline’s program for partnering with academic institutions.

The so-called Discovery Fast Track competition marks the latest attempt by a big drug maker to bolster the discovery of new medicines. Last month, for instance, GSK announced an unusual, potentially $495 million deal to establish several drug-discovery firms with Avalon Ventures.

Research into the molecular underpinnings of disease has furnished a host of discoveries that could be applied to the development of new, more effective medicines. Yet many of these discoveries haven’t been explored, according to industry, government and academic scientists. The National Institutes of Health is now trying to foster this translational research.

Applications to GlaxoSmithKline’s challenge are due July 19. The company expects to announce the winners in October. Read More »

The ongoing patent wars in the mobile industry are one good sign of how valuable intellectual property rights can be for a big company, but here’s an even more immediate example: drug maker Pfizer, which lost its patent over the anti-cholesterol drug Lipitor in late 2011.

Lipitor is still Pfizer’s fifth-best selling product, but it’s a shadow of its former self: in first quarter results announced today, the company said it sold $626 million worth of the drug, down 55% from the same period a year ago.

In fact, six of Pfizer’s top ten drugs declined in sales in the last quarter — more on this after the jump… Read More »

The risks of fake and flawed medicines have leapt from developing nations to Western supply chains, thanks to gaps in oversight of drug wholesalers, lax law enforcement, and ineffective tactics for tracking drugs as they change hands, according to a report released Wednesday by the Institute of Medicine.

“It’s distressing to see vividly just how huge a problem it is in the United States,” said Larry Gostin, a Georgetown University law professor and World Health Organization adviser who led the study. “It's more lucrative to traffic in illegitimate drugs than cocaine or heroin,” he said.

The authors of the FDA-sponsored IOM study note that data and peer-reviewed research is thin and the scope of the problem is elusive. They recommend tighter regulation for drug distributors, a track-and-trace program to monitor the flow of medicines and more global law enforcement coordination.

For years, drug makers have been pushing U.S. regulators to step up enforcement efforts against medicine distributors who import overseas drugs for sale in the U.S. The FDA began a widespread law enforcement push last year, but holes in the supply chain remain.

But the few thousand patients suffering from a deadly hyper-cholesterol disorder now have two new drugs to choose from. This has created an unusual competition in the world of rare-disease treatments—a competition even over how expensive these expensive drugs should be.

The competition was joined this week, when the U.S. Food and Drug Administration approved an injection called Kynamro for the inherited cholesterol disorder. The approval came not long after a pill named Juxtapid was cleared to treat the same condition, homozygous familial hypercholesterolemia.

Treatments for such rare disorders tend to be in the six figures, some of them $400,000 a year or more.

Juxtapid’s maker, Aegerion Pharmaceuticals, priced the pill between $235,000 and $295,000 a year. Then Sanofi’s Genzyme unit divulged their price for Kynamro: $176,000 a year. Although both prices are high, Aegerion acknowledged that the anticipation of competition kept its price from being even more.

“We priced the product and built our sales force and medical marketing and education strategy assuming they will be on the market,” Aegerion CEO Marc Beer said, referring to Genzyme and partner Isis Pharmaceuticals. Yet Beer said Juxtapid sales representatives weren’t going to make direct comparisons with Kynamro.

Genzyme said the competition didn’t play a role in its pricing. “We are on par with” the cost of current treatment for the disorder, said Paula Soteropoulos, a Genzyme official. (That treatment, called apheresis, uses a machine to filter bad cholesterol out of the bloodstream.)

Of course, doctors and patients will look at more than just the price.

The FDA said Juxtapid lowered bad cholesterol by about half during 26 weeks of study in patients who tolerated the drug. Aegerion notes that patients need only swallow a capsule the size of a Tylenol, as opposed to getting an injection. “Aegerion does not expect physicians will prescribe medicine to treat HoFH patients based on cost. These are extremely sick patients and their physicians will select the medicine that they believe has the best benefit / risk profile for their patients,” the company said.

The FDA said Kynamro reduced bad cholesterol levels by an average of 25% during the first 26 weeks of treatment. Genzyme highlights how that more patients participated in the clinical testing of Kynamro (51, according to the FDA) than for Juxtapid (29).

Both drugs carry concerns that long-term use could damage livers.

“This is amazing that patients would actually have options,” said Katherine Wilemon, president of the Familial Hypercholesterolemia Foundation, a group for patients suffering from the hyper-cholesterol disorder. Read More »